April 25, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015 show that the sofosbuvir (SOF)/daclatasvir (DCV) treatment combination is effective amongst hepatitis C virus (HCV) genotype-1 mono-infected patients. These results are significant because whilst other combinations have been widely reported on, there have been few data until now regarding the use of SOF/DCV combination in real world situations.

Overall, the sustained virologic response rate at 4 weeks (SVR4) for SOF/DCV was 81.6% after 12 weeks of treatment and 93.9% following 24 weeks of treatment. The SVR4 rate for SOF/DCV with ribavirin (RBV) was 100% and 96.6% after 12 and 24 weeks, respectively. The 12-week combination of SOF/DCV/RBV achieved a 100% SVR4 rate in cirrhotic patients without the additive effect of extension of the treatment to 24 weeks with or without RBV (95.7% and 92.5%, respectively), and this was also true in experienced patients. All non-cirrhotic patients achieved 100% SVR4 at 12 weeks, demonstrating that the 12-week combination of SOF/DCV is a proven therapeutic option. Importantly, the SVR12 rate was 100% for SOF/DCV/RBV after both 12 and 24 weeks.

"The cohort study has found that the sofosbuvir/daclatasvir combination is associated with a high rate of SVR4 in difficult-to-treat patients infected by genotype-1 hepatitis C. We also found that the combination with ribavirin increases the SVR rate in cirrhotic or experienced patients without the additive effect of the extension of the treatment from 12 to 24 weeks. We hope that this helps support further treatment options for difficult-to-treat patients," said Professor Stanislas Pol, Hôpital Cochin, Paris, France, principal investigator of the French ANRS CO-22 Hepather cohort.

409 HCV genotype-1 mono-infected patients were given a combination of SOF (400 mg/d) and DCV (60 mg/d) without ribavirin (n=318) or with ribavirin (1-1.2 g/d, n=91). 318 patients had cirrhosis and 306 were previously treated with peginterferon-ribavirin (PR) (n=134) or PR + a first generation protease inhibitor (PI) (n=172).

"This study shows very positive results for hepatitis C genotype-1 mono-infected patients. This is one of the first real-life studies looking into sofosbuvir/daclatasvir combinations and has demonstrated that this is a good therapeutic option for these patients. It represents another treatment option to help patients beat hepatitis C," said Professor Tom Hemming Karlsen, Scientific Committee Member, European Association for the Study of the Liver.

Serious adverse events were reported in 9% of patients and treatment discontinuation related to adverse events in 3.1%.

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About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.

Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Introduction: Real-life results of the Sofosbuvir/Simeprevir combination have been extensively reported but there are few data regarding the Sofosbuvir/Daclatasvir combination. In January 2015, 3003 patients of the French observational cohort ANRS CO22 HEPATHER were given the new oral antivirals in 32 centers: we report the preliminary results of the Sofosbuvir/Daclatasvir combination in Genotype 1-infected patients.

Material and Methods: Demographics, history of liver disease were collected at entry in the cohort. Clinical, adverse events, and virological data were collected throughout treatment and post-treatment follow-up.

The overall SVR4 rate was 81.6, 93.9,100 and 96.6% in those who were given for 12 and 24 weeks SOF/DCV and SOF/DCV/RBV, respectively. The overall SVR4 rate differed according to the prior history and fibrosis (Table). The 12-week combination SOF/DCV/RBV achieved a 100% SVR4 rate in cirrhotics without additive effect of extension of the treatment to 24 weeks with or without RBV (95.7 and 92.5, respectively) and this was also true in experienced patients; all non-cirrhotic patients achieved 100% SVR4 at 12 weeks and, thus, the 12-week combination of SOF/DCV is a good therapeutic option. Serious adverse events were only reported in 9% and treatment discontinuation related to adverse events in 3.1%.

Conclusions: The Sofosbuvir/Daclatasvir combination is associated with a high rate of SVR4 in difficult-to-treat patients infected by Genotype 1. The combination of Ribavirin increases the SVR rate in cirrhotic or experienced patients without additive effect of the extension of the treatment from 12 to 24 weeks.

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